Vol. 554 No. 5
1126 Mr. Naughten asked the Minister for Health and Children if his Department will perform research into the possible side effects of the MMR vaccine to allay the fears of many parents and ensure confidence in the vaccination pro gramme; and if he will make a statement on the matter. [16612/02]
The Irish Medicines Board, IMB, is responsible for the monitoring and safety of all pharmaceutical products in Ireland. The monitoring of vaccine safety is ensured through clinical trials prior to licence and post-licence surveillance by the IMB. The IMB liaises closely with international bodies, including the European Medicines Evaluation Agency and the World Health Organisation.
The schedule of immunisation for the childhood immunisation programme is based on the recommendations and expert advice of the Immunisation Advisory Committee of the Royal College of Physicians of Ireland. The committee is made up of experts from associated disciplines in paediatrics, infectious diseases, general practice and public health.
Extensive research has and continues to be conducted world-wide in relation to the MMR vaccine. The World Health Organisation has indicated that MMR vaccine does not cause autism and that there has been no new scientific evidence that would suggest impaired safety of MMR. The WHO strongly endorses the use of MMR vaccine on the grounds of its convincing record of safety and efficacy. The international consensus from professional bodies and international organisations is that MMR is a safe and effective vaccine and that the recently published research does not support a causal link between MMR vaccine and autism or inflammatory bowel disease. The institutions include the Medical Research Council Expert Committee UK, the UK Committee on Safety of Medicines, the Centres for Disease Control and Prevention, CDC, USA and the American Academy of Paediatrics. Recent studies by the United States Institute of Medicine concluded that there is no link between the vaccine and autism or inflammatory bowel disease. This consensus is based on large-scale epidemiological studies and more specific studies done in the laboratory setting. A large Finnish study involving 1.8 million individuals demonstrated that no case of inflammatory bowel disease or autism was linked to the MMR vaccine. A similar Swedish study found no increase in cases of autism in the ten years during which MMR vaccine was introduced. A recent UK study where researchers analysed some 2,000 studies from 180 countries found no evidence of a causal link between MMR vaccine and autism or inflammatory bowel disease.
1127 Mr. Naughten asked the Minister for Health and Children the number of children who have been revaccinated and those who remain to be vaccinated due to the administration of out of date polio vaccine and an ineffective batch of BCG vaccine; if he will give a breakdown in each health board area; and if he will make a statement on the matter. [16613/02]
In early July 2002, I was advised by the Irish Medicines Board, IMB, that a single batch of BCG vaccine, batch number 761641, manufactured by Evans Vaccines Limited was being recalled due to the possibility of reduced effectiveness. This was a precautionary measure following tests which showed that this batch of vaccine, distributed in Ireland since March 2002, was found to be less potent than that which is normally administered. All stock from this batch was withdrawn at this time and is no longer in use. This withdrawal took place under the direction and supervision of the IMB. For precautionary reasons, the use of other batches of Evans BCG vaccine – five in total – was deferred pending testing and confirmation of their effectiveness.
Following this withdrawal, the IMB carried out an on-site investigation of Evans Vaccines facility in the UK; the IMB was dissatisfied with the procedures adopted by the company in producing the BCG vaccine and, as a result of this, on 31 July 2002 the IMB suspended the BCG licence held by Evans Vaccines Limited. Alternative effective supplies of BCG vaccine were secured from Statens Serum Institute, Denmark, and these have been distributed to health boards.
In August 2002, the IMB advised me that following testing of the other five batches manufactured by Evans Vaccines Limited, a further batch of BCG vaccine, batch number 754576, was also found to be sub-potent. This batch was distributed in Ireland between April 2000 and July 2002. The IMB confirmed that the four other batches tested met the licensed potency specification required.
The IMB has assured me that there is no health threat to persons who received BCG vaccine from either batch 761641 or 754576 other than the fact they may not have received immunity from the vaccine. Health boards were asked to identify those who have received vaccine from the two batches concerned, to contact those involved and to make arrangements to examine those who received the vaccine in order to determine whether or not the vaccine was effective at the time it was administered. If it emerges that the vaccine was ineffective, revaccination will be offered. A period of three months must elapse after the BCG vaccine is given before the effectiveness of the vaccine can be determined.
